Compass Pathways
Director, Regulatory Project Management
Compass Pathways, Palm Coast, Florida, United States, 32164
Job Overview
Director, Regulatory Project Management
at
Compass Pathways
will lead the end-to-end project management of a New Drug Application (NDA) submission. The role ensures all activities are strategically planned, efficiently executed, and delivered on time, within scope, and to the highest quality standards. This is a 12‑month contract based in New York City or remote on the East Coast, USA, reporting to the Senior Vice President, Regulatory Affairs. Roles And Responsibilities
Develop, implement, and maintain a comprehensive NDA submission project plan, including detailed timelines, workstreams, milestones, and dependencies. Drive the overall project plan for NDA preparation and submission, ensuring all components are planned, tracked, and delivered on schedule. Define the critical path activities and proactively adjust plans in response to evolving requirements or risks. Align submission activities with overall development program strategy and corporate objectives. Partner with Regulatory Strategy and Operations leads to translate high-level regulatory strategy into detailed, executable submission plans. Establish appropriate submission governance forums and define decision‑making processes to ensure effective risk and issue management. Facilitate effective cross‑functional working sessions to maintain alignment and momentum. Drive collaboration across Clinical, CMC, Nonclinical, Clinical Pharmacology, Safety, Statistics, and Medical Writing to ensure alignment of deliverables. Track document authoring, review, and finalization cycles to provide clear visibility of status across teams, ensuring Content (CTD) is delivered on schedule. Partner with regulatory operations to oversee dossier compilation, quality control, and submission readiness. Proactively identify risks to submission timelines and establish mitigation and contingency plans. Maintain a risk register and ensure issues are tracked, escalated, and resolved in a timely manner. Develop and maintain detailed timelines, trackers, and dashboards to drive execution against critical path activities. Support regulatory operations efforts in publishing, document management, and inspection readiness with internal teams and external vendors. Develop and oversee project plans and timelines for FDA interactions related to the NDA submission, including briefing packages, meeting logistics, and response management. Transition governance from submission execution to lifecycle management and post‑approval commitments. Candidate Profile
Bachelor’s degree in life sciences, pharmacy, or related discipline required; advanced degree (MS, PharmD, PhD, or MBA) preferred. 10+ years of experience in the pharmaceutical/biotech industry, with significant experience in regulatory project management. Demonstrated leadership in managing at least one NDA or BLA submission from initiation through completion; experience managing rolling and/or expedited reviews is a plus. Deep knowledge of FDA regulations, ICH guidelines, and CTD/eCTD structure. Proven ability to manage complex, multi‑disciplinary projects under tight timelines. Proficiency with project management methodologies and tools (e.g., MS Project, Smartsheet, Veeva Vault RIM, or equivalent). Strong organizational, analytical, and facilitation skills, with an ability to influence across functions and levels. Equal Opportunities
Compass Pathways is an equal‑opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex, gender identity, sexual orientation, disability, or any other protected status. Compensation & Benefits
Base salary: $225,000 – $275,000 USD per annum. Compensation includes discretionary bonuses and equity. Benefits include health, dental, vision, life, short‑term and long‑term disability, paid time off, and other standard benefits.
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Director, Regulatory Project Management
at
Compass Pathways
will lead the end-to-end project management of a New Drug Application (NDA) submission. The role ensures all activities are strategically planned, efficiently executed, and delivered on time, within scope, and to the highest quality standards. This is a 12‑month contract based in New York City or remote on the East Coast, USA, reporting to the Senior Vice President, Regulatory Affairs. Roles And Responsibilities
Develop, implement, and maintain a comprehensive NDA submission project plan, including detailed timelines, workstreams, milestones, and dependencies. Drive the overall project plan for NDA preparation and submission, ensuring all components are planned, tracked, and delivered on schedule. Define the critical path activities and proactively adjust plans in response to evolving requirements or risks. Align submission activities with overall development program strategy and corporate objectives. Partner with Regulatory Strategy and Operations leads to translate high-level regulatory strategy into detailed, executable submission plans. Establish appropriate submission governance forums and define decision‑making processes to ensure effective risk and issue management. Facilitate effective cross‑functional working sessions to maintain alignment and momentum. Drive collaboration across Clinical, CMC, Nonclinical, Clinical Pharmacology, Safety, Statistics, and Medical Writing to ensure alignment of deliverables. Track document authoring, review, and finalization cycles to provide clear visibility of status across teams, ensuring Content (CTD) is delivered on schedule. Partner with regulatory operations to oversee dossier compilation, quality control, and submission readiness. Proactively identify risks to submission timelines and establish mitigation and contingency plans. Maintain a risk register and ensure issues are tracked, escalated, and resolved in a timely manner. Develop and maintain detailed timelines, trackers, and dashboards to drive execution against critical path activities. Support regulatory operations efforts in publishing, document management, and inspection readiness with internal teams and external vendors. Develop and oversee project plans and timelines for FDA interactions related to the NDA submission, including briefing packages, meeting logistics, and response management. Transition governance from submission execution to lifecycle management and post‑approval commitments. Candidate Profile
Bachelor’s degree in life sciences, pharmacy, or related discipline required; advanced degree (MS, PharmD, PhD, or MBA) preferred. 10+ years of experience in the pharmaceutical/biotech industry, with significant experience in regulatory project management. Demonstrated leadership in managing at least one NDA or BLA submission from initiation through completion; experience managing rolling and/or expedited reviews is a plus. Deep knowledge of FDA regulations, ICH guidelines, and CTD/eCTD structure. Proven ability to manage complex, multi‑disciplinary projects under tight timelines. Proficiency with project management methodologies and tools (e.g., MS Project, Smartsheet, Veeva Vault RIM, or equivalent). Strong organizational, analytical, and facilitation skills, with an ability to influence across functions and levels. Equal Opportunities
Compass Pathways is an equal‑opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex, gender identity, sexual orientation, disability, or any other protected status. Compensation & Benefits
Base salary: $225,000 – $275,000 USD per annum. Compensation includes discretionary bonuses and equity. Benefits include health, dental, vision, life, short‑term and long‑term disability, paid time off, and other standard benefits.
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